Code A: Annex A - Legislative background

1. The Human Tissue Authority (HTA) is the regulator for human organs, tissues and cells. The HTA was established by the Human Tissue Act 2004 (HT Act) in 2005, following the discovery of establishments removing and retaining human organs and tissue without consent. The HT Act addressed this issue and brought together other existing laws that related to human tissue and organs.

2. The HT Act applies to the removal, storage and use of human organs and tissue for scheduled purposes⁶;in England, Wales and Northern Ireland, with the exception of the provisions relating to the use of DNA, which also apply to Scotland.

3. Under section 14(3) of the HT Act, the HT Act and the guidance given in the Codes of Practice do not apply to bodies or relevant material where:

• the person died before the HT Act came into force on 1 September 2006
• at least 100 years have elapsed since the date of the person’s death.

4. The Human Tissue Act 2004 (Persons who Lack Capacity to Consent and Transplants) Regulations 2006 (the Regulations) lay down the responsibilities of the HTA in relation to the donation of transplantable material from living donors, including those who lack capacity to consent.

5. The Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations), as amended, implemented into UK law the European Union Tissue and Cells Directive 2004/23/EC (EUTCD). The Q&S Regulations set out the standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells for human application. In their amended form following UK’s exit from the European Union, the Q&S Regulations modify the requirements of the EUTCD as applied to Great Britain to reflect the departure from the EU, but the same standards continue to apply. Those modifications do not apply to Northern Ireland where the HTA remains the Competent Authority for the purposes of the EUTCD.

6. Establishments licensed under the Q&S Regulations should refer to the HTA’s Guide to Quality and Safety Assurance for Human Tissues and Cells for Patient Treatment and the requirements set out in Codes A and G.

7. The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (the Q&S (Organs) Regulations) implemented into UK law the European Union Organ Donation Directive 2010/53/EU (EUODD). The Q&S (Organs) Regulations set quality and safety standards for organ donation and transplantation. In their amended form following UK’s exit from the European Union, the Q&S (Organs) Regulations modify the requirements of the EUODD as they apply to Great Britain, but the same standards continue to apply. Those modifications do not apply to Northern Ireland where the HTA remains the Competent Authority for the purposes of the EUODD. Establishments licensed under the Q&S (Organs) Regulations should refer to the HTA’s Quality and Safety of Organs Intended for Transplantation: a documentary framework and the requirements set out in Codes A and F (parts one and two).

8. A deemed consent system for organ and tissue donation after death is operational in England, Wales and Northern Ireland. This does not have an impact on the HTA’s regulation of living organ donation. These Codes of Practice do not apply to organ and tissue donation from the deceased in Wales; the HTA has published a Code of Practice on the Human Transplantation (Wales) Act 2013 for establishments in Wales.  

9. The HTA’s remit does not extend to Scotland, and therefore the HTA’s Codes of Practice do not apply to establishments in Scotland. 

10. The Human Tissue (Scotland) Act 2006 (HT (Scotland) Act) and the Human Tissue (Authorisation) (Scotland) Act 2019 apply in Scotland.

11. The HTA assesses applications for living organ donation and donation of regenerative tissue on behalf of Scottish Ministers who delegated this responsibility to the HTA. The law in Scotland is significantly different from that in the rest of the UK, so this Code does not apply in Scotland

12. Throughout the Codes, the word ‘must’ applies to all legal requirements derived from primary and secondary legislation (for example, the legal requirement to hold a licence to store human tissue for use for a scheduled purpose, the conditions of any licence and the requirements set out in any directions issued by the HTA). It also applies to the duty to abide by the HTA’s licensing Standards. We use the word ‘should’ when providing advice on how to meet these requirements.

13. Establishments are expected to follow the guidance contained in the Codes. Observance of the guidance is one of the ways in which the HTA assesses that establishments are complying with legal requirements. Failure to follow a Code of Practice is not in itself a criminal offence under the HT Act, but the HTA will consider carefully any breach of a Code of Practice when considering whether there are grounds to take regulatory action
 

14. The Codes of Practice complement each other and should be read alongside other relevant advice and guidance, which is either referenced in the text or provided on the HTA’s website. The Codes of Practice may also refer to guidance which has been produced by a number of other organisations. The HTA is not responsible for the content of others’ guidance, but does recommend that practitioners follow this guidance when they fall within its remit. Guidance that has been produced in collaboration with the HTA will appear on our website.

15. The HTA’s Codes of Practice and other HTA guidance should, however, be used as the definitive source of information for issues within our remit. If you are in any doubt, please contact the HTA or seek your own legal advice. Regulated sectors should also keep up to date with other relevant legislation.

16. Medical schools and research establishments may charge for providing human tissue to others for training and research, including those working for private companies so that the costs of providing the tissue are recovered. Where cost recovery, or any other charging mechanism, is in place it is important that establishments are able to satisfy themselves that the information provided to potential donors is sufficient to ensure they understand that their tissue may be shared, subject to a fee being charged. The HTA also recommends that establishments ensure transparency by providing easily accessible information about how and why they charge, and to whom they will supply tissue samples. This is important to ensure that the consent sought from donors is fully informed.

6. Defined by the HT Act and explained in further detail in the glossary.